情報リーフレット
LANZEK
®
AND
LANZEK
®
ZYDIS
®
_olanzapine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information and does not take the
place of talking with your doctor.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
about this medicine may be available.
Make sure you speak to your
pharmacist or doctor to obtain the
most up to date information on this
medicine. You can also download the
most up to date leaflet from
www.lilly.com.au . The updated
leaflet may contain important
information about LANZEK and its
use that you should be aware of.
All medicines have risks and
benefits.
Your doctor has more information
about this medicine than is contained
in this leaflet. Also, your doctor has
had the benefit of taking a full and
detailed history from you and is in
the best position to make an expert
judgement to meet your individual
needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT LANZEK IS USED
FOR
LANZEK belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause mental
illness.
LANZEK is used to treat symptoms
of schizophrenia and related
psychoses. Schizophrenia is a mental
illness with disturbances in thinking,
feelings and behaviour.
LANZEK alone, or in combination
with lithium or valproate, is used for
the short-term treatment of acute
manic episodes associated with
Bipolar I Disorder. LANZEK is also
a mood stabiliser that prevents
further occurrences of the disabling
high and low (depressed) extremes of
mood associated with Bipolar I
Disorder.
Bipolar I Disorder is a mental illness
with symptoms such as feeling
"high", having excessive amounts of
energy, needing much less sleep than
usual, talking very quickly with
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製品の特徴
Lanzek & Lanzek-Zydis-pi-v3.0
Page 1 of 18
LANZEK
®
AND LANZEK
®
ZYDIS
®
(olanzapine)
NAME OF THE MEDICINE
LANZEK
LANZEK ZYDIS (olanzapine).
Chemically, olanzapine is
2-methyl-4-(4-methyl-1-piperazinyl)-10_H_-thieno[2,3-_b_]
[1,5]benzodiazepine and its empirical formula is C
17
H
20
N
4
S. Olanzapine is a yellow
crystalline solid, practically insoluble in water
with a molecular weight of 312.44. The CAS
number for olanzapine is 132539-06-1.
Olanzapine has the following structural formula:
N
N
S
C H
N
N
C H
H
DESCRIPTION
LANZEK:
LANZEK tablets are white, film coated tablets for oral
administration. The active ingredient
in LANZEK tablets is olanzapine. LANZEK tablets
also contain excipients: lactose,
hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate,
hypromellose and carnauba wax. LANZEK 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets
also
contain Colour Mixture White YS-1-18027-A and Edible Blue Ink.
LANZEK ZYDIS:
LANZEK ZYDIS wafers are
a freeze dried, rapid-dispersing preparation to be placed in the
mouth or alternatively to be dispersed in water or other
suitable beverage (not cola
beverages) for administration. LANZEK ZYDIS wafers are
yellow. The active ingredient in
LANZEK ZYDIS wafers is
olanzapine. LANZEK ZYDIS wafers also contain excipients:
gelatin, mannitol, aspartame, sodium methyl
hydroxybenzoate and sodium propyl
hydroxybenzoate.
PHARMACOLOGY
PHARMACODYNAMICS
Olanzapine is an atypical antipsychotic, antimanic
and mood stabilising agent that
demonstrates a broad pharmacological profile across a number
of receptor systems.
In preclinical
studies, olanzapine exhibited a range of receptor affinities
(Ki; < 100 nmol) for
serotonin 5HT
2A/2C
, 5HT
3
, 5HT
6
; dopamine D
1
, D
2
, D
3
, D
4
, D
5
; cholinergic musc
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